Indications and uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
LORATADINE SOFTGELS
- Manufacturer
- Wal-Mart Stores Inc | TIME CAP LABS INC | MARKSANS PHARMA LIMITED
- Effective date
- 2018-05-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:55:45
Label at a glance#
ProductLORATADINE SOFTGELS
Active ingredientLORATADINE
Label structure8 sections
Dosage and administration
ADULTS AND CHILDREN 6 YEARS AND OVER: 1 CAPSULE DAILY; NOT MORE THAN 1 CAPSULE IN 24 HOURS. CHILDREN UNDER 6 YEARS OF AGE: ASK A DOCTOR. CONSUMERS WITH LIVER OR KIDNEY DISEASE: ASK A DOCTOR.
Storage and handling
STORE BETWEEN 20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT) PROTECT FROM FREEZING
Label contents#
Full prescribing information#
Active ingredient(in each capsule)
Loratadine 10 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Warnings
DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS.
WHEN USING THIS PRODUCT DO NOT TAKE MORE THAN DIRECTED. TAKING MORE THAN DIRECTED MAY CAUSE DROWSINESS.
STOP USE AND ASK A DOCTOR IF AN ALLERGIC REACTION TO THIS PRODUCT OCCURS. SEEK MEDICAL HELP RIGHT AWAY.
IF PREGNANT OR BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
OTC - DO NOT USE SECTION
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
OTC - WHEN USING SECTION
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if
- an allergic reaction to this product occurs. Seek medical help right away.
- side effects occur.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health care professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
ADULTS AND CHILDREN 6 YEARS AND OVER: 1 CAPSULE DAILY; NOT MORE THAN 1 CAPSULE IN 24 HOURS.
CHILDREN UNDER 6 YEARS OF AGE: ASK A DOCTOR.
CONSUMERS WITH LIVER OR KIDNEY DISEASE: ASK A DOCTOR.
Other information
STORE BETWEEN 20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT)
PROTECT FROM FREEZING
Inactive ingredients
FD&C BLUE #1, GELATIN, MONO AND DIGLYCERIDE OF CAPRYLIC/CAPRIC ACID, PHARMACEUTICAL INK, POLYSORBATE 80, POVIDONE, PURIFIED WATER, SORBITOL SORBITAN SOLUTION.
NDC 49035-686-30
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49035-686-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f980-f424-e053-dadaa90a57ce | WALMART 686T |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-686-30 | LORATADINE SOFTGELS | 30 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 30 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- LORATADINE SOFTGELS
- Loratadine
- WATER
- FD&C BLUE NO. 1
- GELATIN
- SORBITOL
- GLYCERYL CAPRYLOCAPRATE
- POLYSORBATE 80
- POVIDONES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49035-686 | 49035-686-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| SORBITOL | 506T60A25R | IACT |
| GLYCERYL CAPRYLOCAPRATE | U72Q2I8C85 | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POVIDONES | FZ989GH94E | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206214-001 | LORATADINE | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | f41ea6bd6efb… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6c50fcac-b085-4473-e053-2a91aa0ae265 | 6c50fcac-b084-4473-e053-2a91aa0ae265 | 2018-05-16 | Warnings | 6c50fcac-b085-4473-e053-2a91aa0ae265 6c50fcac-b084-4473-e053-2a91aa0ae265 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.